Gas Module II, Model 0998-00-0143
FDA 510(k) K974903 · Datascope Corp.
510(k) numberK974903
Submission
- Device name
- Gas Module II, Model 0998-00-0143
- Applicant
- Datascope Corp.
Paramus, NJ, US - Received
- December 31, 1997
- Decision date
- March 13, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CBS – Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1620
- Specialty
- Anesthesiology
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Questions and answers
When was Gas Module II, Model 0998-00-0143 cleared by the FDA?
Gas Module II, Model 0998-00-0143 (K974903) received a 510(k) decision of Substantially Equivalent on March 13, 1998, 72 days after the submission was received.
What is the product code of K974903?
The FDA product code is CBS – Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.), a Class II (moderate risk) device regulated under 21 CFR 868.1620.